Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Recruiting
Phase 3Interventional Study
Focal SeizureEpilepsyFocal Epilepsy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
312 (estimated)
Sponsor
Rapport Therapeutics Inc. · Industry
Who this trial is looking for
This trial is looking for adults with focal seizures to test a new drug called RAP-219. Participants will keep daily records of their seizures during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
My body mass index (BMI) is between 18 and 45.
I have been diagnosed with focal epilepsy for at least 2 years.
I have had a brain MRI or CT scan and an EEG study in the last 10 years that confirm my diagnosis.
I am taking 1 to 3 anti-seizure medications for maintenance.
I can keep daily records of my seizures using an e-diary.
You may not be able to join if
I am allergic to or have taken RAP-219 before.
I have an uncontrolled serious medical or psychiatric condition.
I need surgery during the study period.
I have had generalized epilepsy.
I only experience a specific type of seizure without observable signs.
I have had psychogenic nonepileptic seizures.
I have experienced status epilepticus or seizure clusters in the last 12 months.
I have had epilepsy surgery in the last 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18 - 75
2. BMI 18-45 kg/m2
3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis
5. Concomitant use of betwee…
Inclusion Criteria:
1. Age 18 - 75
2. BMI 18-45 kg/m2
3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis
5. Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
6. Ability to keep accurate daily focal seizure records using an e-diary
Exclusion Criteria:
1. Known hypersensitivity or prior exposure to RAP-219.
2. Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur
3. Anticipated need for surgery during the study period
4. Medical history of any of the following:
1. generalized epilepsy
2. focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type
3. psychogenic nonepileptic seizure (PNES)
4. status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).
5. epilepsy surgery within 12 months prior to Visit 1 (Day -56).
5. Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
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